Diabetes Trial Files: GEMI + DAPA Add-On in T2DM, Triple Combination Therapy, and Semaglutide in CKD & T2DM
Dual add-on therapy of gemigliptin and dapagliflozin in patients with type 2 diabetes inadequately controlled with metformin alone (SOLUTION 2)
Han KA et al. Diabetes, Obesity and Metabolism (September 2024)
Bottom Line: This phase 3, randomized, double-blind, double-dummy, active-controlled, parallel-group study evaluated the efficacy and safety of gemigliptin and dapagliflozin dual add-on therapy (GEMI + DAPA) compared to single add-on therapy with either gemigliptin (GEMI) or dapagliflozin (DAPA) to metformin in 469 type 2 diabetes (T2D) patients with inadequate glycaemic control on metformin alone. The primary outcome was a change in HbA1c levels from baseline at week 24, with GEMI + DAPA showing superiority over both GEMI and DAPA. The incidence of adverse events was low and similar among groups. The addition of GEMI + DAPA was effective, safe, and well-tolerated for T2D patients with inadequate glycaemic control on metformin alone.
Efficacy and tolerability of initial triple combination therapy with metformin, dapagliflozin and saxagliptin compared with stepwise add-on therapy in drug-naïve patients with type 2 diabetes (TRIPLE-AXEL)
Kim NH et al. Diabetes, Obesity and Metabolism (June 2024)
Bottom Line: This was a 104-week, multicentre, randomized, open-label trial comparing initial triple combination therapy (TCT) to conventional stepwise add-on therapy (SAT) in 105 newly diagnosed type 2 diabetes patients. The primary outcome was the proportion of patients achieving HbA1c level of less than 6.5% without hypoglycaemia, weight gain of 5% or higher, or discontinuation of drugs at week 104. TCT was found to be more effective in achieving this outcome (39.0% vs. 17.1% for SAT) with a risk difference of 22.0. TCT was also better tolerated and had fewer adverse events compared to SAT. This suggests that TCT may be a novel strategy for initial combination therapy in T2D patients.
Effects of Semaglutide on Chronic Kidney Disease in Patients with Type 2 Diabetes
Perkovic V et al. NEJM (May 2024)
Bottom Line: This randomized controlled trial, known as the FLOW trial, evaluated the effects of subcutaneous semaglutide at a dose of 1.0 mg weekly in patients with type 2 diabetes and chronic kidney disease. The study included 3533 participants and had a median follow-up of 3.4 years. The primary outcome was major kidney disease events, and the results showed a 24% lower risk in the semaglutide group compared to the placebo group. The study also found a lower risk of major cardiovascular events and death from any cause in the semaglutide group. The results for all confirmatory secondary outcomes favored semaglutide. Serious adverse events were reported in a lower percentage of participants in the semaglutide group. In conclusion, semaglutide reduced the risk of clinically important kidney outcomes and death from cardiovascular causes in patients with type 2 diabetes and chronic kidney disease.
Diabetes Trial Files Issue #DIA-2024-03
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